Effect of Consumption of Chaya on Lipid Concentration and Antioxidant Status of Patients With Dyslipidemia
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Chaya (Cnidoscolus chayamansa)
Sponsored by
About this trial
This is an interventional prevention trial for Dyslipidemias
Eligibility Criteria
Inclusion Criteria:
- Male and female.
- Adults between 20 and 60 years.
- BMI ≥ 20 and ≤ 39.9 kg / m².
- Mestizo Mexicans: parents and grandparents born in Mexico.
- Patients diagnosed with dyslipidemia.
- Dyslipidemia will be defined by any? alteration in the concentrations of the following lipoproteins: LDL cholesterol> 130mg/dL or total cholesterol> 200 mg/dL or triglycerides> 150 mg/dL
- Patients should know how to read and write.
- Signature of informed consent.
Exclusion Criteria:
- Patients with any type of diabetes previously diagnosed
- Patients with acquired diseases that produce secondary obesity and diabetes.
- Patients who have suffered a cardiovascular event.
- Weight loss> 3 kg in the last 3 months.
- Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
- Positive smoking.
Drug treatment:
- Antihypertensive drugs (thiacyclic, loop or potassium-sparing diuretics, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).
Sites / Locations
- Hospital Regional de Alta Especialidad de la Península de Yucatán
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chaya (Cnidoscolus chayamansa)
Arm Description
Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.
Outcomes
Primary Outcome Measures
Change from baseline triglycerides concentration at 6 weeks of intervention
Serum triglyceride measurement by the method of colorimetry enzymatic
Change from baseline Lipoproteins concentration at 6 weeks of intervention
Total cholesterol, LDL and HDL measurement by the method of colorimetry enzymatic
Secondary Outcome Measures
Change from baseline blood gene expression of superoxide dismutase at 6 weeks of intervention
Gene expression of superoxide dismutase measurement by qPCR method
Change from baseline blood gene expression of catalase at 6 weeks of intervention
Blood gene expression of catalase measurement by quantitative polymerase chain reaction (qPCR) method
Change from baseline serum antioxidant activity at 6 weeks of intervention
Serum antioxidant activity measurement by spectrophotometric method
Change from baseline serum C-Reactive Protein at 6 weeks of intervention
Serum C-Reactive Protein measurement by the method of colorimetry enzymatic
Full Information
NCT ID
NCT04110392
First Posted
September 26, 2019
Last Updated
February 8, 2021
Sponsor
Hospital Regional de Alta Especialidad de la Península de Yucatán
1. Study Identification
Unique Protocol Identification Number
NCT04110392
Brief Title
Effect of Consumption of Chaya on Lipid Concentration and Antioxidant Status of Patients With Dyslipidemia
Official Title
Effect of Consumption of a Beverage of Chaya (Cnidoscolus Chayamansa) on Lipid Concentration, Lipid Peroxidation and Antioxidant Status of Patients With Dyslipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Regional de Alta Especialidad de la Península de Yucatán
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Currently, the changes generated in lifestyle, such as excessive consumption of saturated fats and refined carbohydrates, as well as the decrease in the intake of fiber, fruits, vegetables and antioxidants, as well as physical inactivity, have generated an increase in the prevalence of dyslipidemias. Dyslipidemias are a disorder of blood lipid and lipoprotein concentration, which increases the risk of developing atherosclerosis and cardiovascular diseases. In Mexico, the dyslipidemias are present in one in four Mexicans over 20 years old. However, in Yucatan increases this frequency increases due to one in three people suffer from dyslipidemia. Its prevalence is even higher in overweight subjects, diabetes and high blood pressure. Thus, it is important to search for strategies to reduce dyslipidemias, as well as the complications associated with them. The treatment and prevention of dyslipidemia is through dietary treatment, which may be accompanied by the consumption of foods that generate beneficial health effects due to the presence of bioactive compounds. Chaya (Cnidoscolus chayamansa) is a plant use in popular medicine to treat medicine in the treatment of chronic degenerative diseases. It contained different bioactive compounds such as flavonoids, vitamin C and polyphenols such as quercetin and kaempferol. Compounds that have been assigned various beneficial effects such as decreased triglyceride concentrations, cholesterol, malondialdehyde, C-Reactive protein, oxidized LDL, which are alterations that are present in dyslipidemia. Therefore, the consumption of this food could be an adequate strategy for subjects with dyslipidemia in Yucatan and Mexico due to the anti-inflammatory and antioxidant effects, and could reduce the risk of developing atherosclerosis and cardiovascular diseases.
Detailed Description
The protocol will be carried out in the Hospital Regional de Alta Especialidad de la Península de Yucatán (HRAEPY). It is quasi-experimental and it was proposed before and after study, the study will be consisting in 6 subsequent visits and a last visit to deliver results to the participant.
In the pre-visit, the subjects will be evaluated to determine if they meet the inclusion criteria. They will be explained what the study consists of, the characteristics, the risks and the expected benefits after the intervention, they will be asked to read the consent letter, doubts will be clarified about it and if the participant agrees to be in the study the signature will be made of the consent letter.
At the beginning and end will be taken two blood samples of 5 mL to each participant. One will be to obtain the serum and measure cholesterol-HDL, cholesterol-LDL, triglycerides, total cholesterol, glucose, antioxidant activity, malondialdehyde (MDA) and C-reactive protein. The second sample will be to the extraction of peripheral leukocyte blood mononuclear cells and determine the gene expression of antioxidants enzymes superoxide dismutase (SOD) and catalase (CAT). Blood pressure will be measured with a digital baumanometer while the participant will remain seated with the right arm uncovered. The measurement will be carried out 6 times, in intervals of 3 minutes. The first measurement will be discarded and the average of the remaining measurements will be reported. In the visits will bring to each participant an attachment to reported intake of the beverage. During the following ones it will always be questioned if there is any problem with the drinking the beverage of Chaya.
At the end of the study, participants will be given the document with their results and will be given recommendations for weight control, dietary recommendations to improve lipid concentrations. They will refer to their doctor for follow-up with their laboratory results for their control.
Description of the intervention
Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
It is quasi-experimental and it was proposed before and after study, the study will be consisting of a pre-visit, 6 subsequent visits and a last visit to deliver results to the participant.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chaya (Cnidoscolus chayamansa)
Arm Type
Experimental
Arm Description
Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chaya (Cnidoscolus chayamansa)
Intervention Description
Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.
Primary Outcome Measure Information:
Title
Change from baseline triglycerides concentration at 6 weeks of intervention
Description
Serum triglyceride measurement by the method of colorimetry enzymatic
Time Frame
At the beginning of the study and after 6 weeks of intervention
Title
Change from baseline Lipoproteins concentration at 6 weeks of intervention
Description
Total cholesterol, LDL and HDL measurement by the method of colorimetry enzymatic
Time Frame
At the beginning of the study and after 6 weeks of intervention
Secondary Outcome Measure Information:
Title
Change from baseline blood gene expression of superoxide dismutase at 6 weeks of intervention
Description
Gene expression of superoxide dismutase measurement by qPCR method
Time Frame
At the beginning of the study and after 6 weeks of intervention
Title
Change from baseline blood gene expression of catalase at 6 weeks of intervention
Description
Blood gene expression of catalase measurement by quantitative polymerase chain reaction (qPCR) method
Time Frame
At the beginning of the study and after 6 weeks of intervention
Title
Change from baseline serum antioxidant activity at 6 weeks of intervention
Description
Serum antioxidant activity measurement by spectrophotometric method
Time Frame
At the beginning of the study and after 6 weeks of intervention
Title
Change from baseline serum C-Reactive Protein at 6 weeks of intervention
Description
Serum C-Reactive Protein measurement by the method of colorimetry enzymatic
Time Frame
At the beginning of the study and after 6 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female.
Adults between 20 and 60 years.
BMI ≥ 20 and ≤ 39.9 kg / m².
Mestizo Mexicans: parents and grandparents born in Mexico.
Patients diagnosed with dyslipidemia.
Dyslipidemia will be defined by any? alteration in the concentrations of the following lipoproteins: LDL cholesterol> 130mg/dL or total cholesterol> 200 mg/dL or triglycerides> 150 mg/dL
Patients should know how to read and write.
Signature of informed consent.
Exclusion Criteria:
Patients with any type of diabetes previously diagnosed
Patients with acquired diseases that produce secondary obesity and diabetes.
Patients who have suffered a cardiovascular event.
Weight loss> 3 kg in the last 3 months.
Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
Positive smoking.
Drug treatment:
Antihypertensive drugs (thiacyclic, loop or potassium-sparing diuretics, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azalia Avila Nava, PhD
Organizational Affiliation
Hospital Regional de Alta Especialidad de la Península de Yucatán
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional de Alta Especialidad de la Península de Yucatán
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97130
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24333962
Citation
Garcia-Rodriguez RV, Gutierrez-Rebolledo GA, Mendez-Bolaina E, Sanchez-Medina A, Maldonado-Saavedra O, Dominguez-Ortiz MA, Vazquez-Hernandez M, Munoz-Muniz OD, Cruz-Sanchez JS. Cnidoscolus chayamansa Mc Vaugh, an important antioxidant, anti-inflammatory and cardioprotective plant used in Mexico. J Ethnopharmacol. 2014 Feb 3;151(2):937-43. doi: 10.1016/j.jep.2013.12.004. Epub 2013 Dec 11.
Results Reference
background
PubMed Identifier
20492237
Citation
Loarca-Pina G, Mendoza S, Ramos-Gomez M, Reynoso R. Antioxidant, antimutagenic, and antidiabetic activities of edible leaves from Cnidoscolus chayamansa Mc. Vaugh. J Food Sci. 2010 Mar;75(2):H68-72. doi: 10.1111/j.1750-3841.2009.01505.x.
Results Reference
background
PubMed Identifier
10540979
Citation
Kuti JO, Kuti HO. Proximate composition and mineral content of two edible species of Cnidoscolus (tree spinach). Plant Foods Hum Nutr. 1999;53(4):275-83. doi: 10.1023/a:1008081501857.
Results Reference
background
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Effect of Consumption of Chaya on Lipid Concentration and Antioxidant Status of Patients With Dyslipidemia
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